(88 days)
Not Found
No
The device description focuses on the mechanical components and materials of a total elbow prosthesis. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is an implant designed to replace the articulating surfaces of and restore motion to the humeroulnar (elbow) joint, treating conditions like arthritis and instability. This function directly aligns with the definition of a therapeutic device, which aims to treat or alleviate a medical condition.
No
This device is an implant designed to replace the articulating surfaces of the elbow joint, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "total elbow prosthesis" and lists physical components made of titanium alloy, polyethylene, and cobalt-chromium-molybdenum alloy. This indicates a physical implant, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Zimmer Nexel Total Elbow is a surgical implant designed to replace the physical structure of the elbow joint. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended uses listed are all related to treating physical conditions of the elbow joint through surgical replacement. They do not involve analyzing biological samples for diagnostic purposes.
Therefore, the Zimmer Nexel Total Elbow falls under the category of a medical device, specifically a prosthetic implant, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indications for use include:
- Elbow joint destruction which significantly compromises the activities of daily living -
- Post-traumatic lesions or bone loss contributing to elbow instability -
- Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis -
- Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain -
- Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
- Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
- Revision arthroplasty
Caution: This device is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JDC
Device Description
The Zimmer Nexel total Elbow is a total elbow prosthesis designed for use with bone cement. It is available in multiple sizes and in right and left configurations.
How the Device Functions: The Zimmer Nexel Total Elbow is an implant designed to replace the articulating surfaces of and restore motion to the humeroulnar (elbow) joint. The implant is a constrained device assembly and consists of the following components: humeral component, ulnar component, humeral bearing-A, ulnar bearings-B, axle pin and humeral screws.
The Following Scientific Concepts, Design Features and Physical Properties form the Basis for the Zimmer Nexel Total Elbow: The humeral component has a humeral stem designed to be implanted with bone cement into the patient's humeral medullary canal, an anterior flange designed to accept a bone graft and limit torsional and posterior migration, a humeral yoke with rounded corners to avoid the creation of stress risers within the medial and lateral humeral supracondylar columns, and plasma spray region to enhance fixation to bone cement within the medullary canal, and to improve fatigue strength. The ulnar component has an ulnar stem designed to be implanted with bone cement into the patient's ulnar medullary canal, an ulnar eye that is both highly polished and nitrogen-enriched to limit wear of the apposing polymer bearings, and plasma spray region to enhance fixation to bone cement within the medullary canal. Bearings A and B are designed to broadly distribute joint reaction forces.
Materials Used: The humeral and ulnar components are made of a titanium alloy, the bearings A and B are made of Vitamin E highly cross-linked polyethylene, and the humeral screws and axle pin are made of a cobalt-chromium-molybdenum alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow joint / humeroulnar (elbow) joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing Conducted:
Performance Data:
-Stem Fatigue Testing
-Wear Testing
-Durability Testing
-Modular Connection Fatigue Testing
Non-Clinical Performance Testing Conclusions: Non-clinical testing demonstrated that the New Zimmer Total Elbow meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy.
In this case, clinical data and conclusions were not needed to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,”
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
1/3
a
MAR 1 2 2013
Image /page/0/Picture/3 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter Z inside of a circle. Below the circle is the word "zimmer" in a smaller, sans-serif font.
510(k) Summary of Safety and Effectiveness
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joanna L. Surma
Associate Project Manager, Regulatory Affairs |
| Telephone: | (574) 371-1642 |
| Fax: | (574) 372-4605 |
| Date: | 13 December 2012 |
| Trade Name: | Zimmer Nexel Total Elbow |
| Common Name: | Total Elbow Prosthesis |
| Classification | 21 CFR § 888.3150
Elbow joint metal/polymer constrained cemented prosthesis |
| Product Code: | JDC – Prosthesis, Elbow, Constrained, Cemented |
| Predicate Device: | Coonrad/Morrey Total Elbow, manufactured by Zimmer,
K001989, cleared 25 July 2000 |
| | Coonrad/Morrey Total Elbow, manufactured by Zimmer,
K053189, cleared 9 December 2005 |
| Device Description: | The Zimmer Nexel total Elbow is a total elbow prosthesis
designed for use with bone cement. It is available in multiple
sizes and in right and left configurations. |
| | How the Device Functions: The Zimmer Nexel Total Elbow is
an implant designed to replace the articulating surfaces of and
restore motion to the humeroulnar (elbow) joint. The implant is a
constrained device assembly and consists of the following
components: humeral component, ulnar component, humeral
bearing-A, ulnar bearings-B, axle pin and humeral screws. |
| | The Following Scientific Concepts, Design Features and
Physical Properties form the Basis for the Zimmer Nexel
Total Elbow: The humeral component has a humeral stem
designed to be implanted with bone cement into the patient's
humeral medullary canal, an anterior flange designed to accept a |
1
bone graft and limit torsional and posterior migration, a humeral yoke with rounded corners to avoid the creation of stress risers within the medial and lateral humeral supracondylar columns, and plasma spray region to enhance fixation to bone cement within the medullary canal, and to improve fatigue strength. The ulnar component has an ulnar stem designed to be implanted with bone cement into the patient's ulnar medullary canal, an ulnar eye that is both highly polished and nitrogen-enriched to limit wear of the apposing polymer bearings, and plasma spray region to enhance fixation to bone cement within the medullary canal. Bearings A and B are designed to broadly distribute joint reaction forces.
Materials Used: The humeral and ulnar components are made of a titanium alloy, the bearings A and B are made of Vitamin E highly cross-linked polyethylene, and the humeral screws and axle pin are made of a cobalt-chromium-molybdenum alloy.
Comparison to the Predicate: The proposed device (Zimmer Nexel Total Elbow) and the predicate device (Coonrad/Morrey Total Elbow) have the same intended use and similar indications for use. The proposed device humeral and ulnar components are very similar in terms of materials used and design/dimensions to the predicate device humeral and ulnar components. The primary differences between the proposed and predicate devices are that the proposed device bearing components are made of Vitamin E highly cross-linked polyethylene (the predicate device bearing components are made of ultra-high molecular-weight polyethylene), and the proposed device has bearings that articulate on both the outer and inner diameters of the ulnar eve (the predicate device has bearings that articulate on the inner diameter of the ulnar eye). Additionally, the proposed device uses screws and a 1-part axle pin to fix the bearings in place, while the predicate device uses a 2-part (snap-fit) axle pin.
Intended Use:
Indications for use include:
- Elbow joint destruction which significantly compromises the activities of daily living ー
- Post-traumatic lesions or bone loss contributing to elbow instability -
- Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis -
- Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain -
- Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
- Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
- Revision arthroplasty
Caution: This device is intended for cemented use only.
2
510(k) Summary of Safety and Effectiveness – Zimmer Nexel Total Elbow
The Zimmer Nexel Total Elbow is substantially equivalent to the Comparison to Predicate Device: predicate device in terms of form and function. The Zimmer Nexel Total Elbow and the predicate device share similar intended uses and indications for use. Non-Clinical Performance Testing Conducted: Performance Data: Stem Fatigue Testing --Wear Testing -Durability Testing Modular Connection Fatigue Testing -Non-Clinical Performance Testing Conclusions:
Non-clinical testing demonstrated that the New Zimmer Total Elbow meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy.
In this case, clinical data and conclusions were not needed to demonstrate substantial equivalence.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Letter dated: March 12, 2013
Food and Drug Administratio 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Incorporated % Ms. Joanna L. Surma Associate Project Manager, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K123862
Trade/Device Name: Zimmer Nexel Total Elbow Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: JDC Dated: December 13, 2012 Received: December 14, 2012
Dear Ms. Surma:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Joanna L. Surma
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N.INielkerson -S
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ___ K123862
Device Name:
Zimmer Nexel Total Elbow
Indications for Use:
Indications for use include:
- Elbow joint destruction which significantly compromises the activities of daily living -
- Post-traumatic lesions or bone loss contributing to elbow instability -
- Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis
- Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain
- Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
- Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
- Revision arthroplasty -
CAUTION: This device is intended for cemented use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. { Hanley Ph: D Division of Orthopaedic Devices
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